MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR; STENT, URETERAL

Model Number	M0061802220
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that a contour ureteral stent was to be used in a procedure.During unpacking, it was found that the front end of the product was adhered and the middle part was fractured.The procedure was completed with another of the same device and there were no patient complications reported.
Event or Problem Description
It was reported that a contour ureteral stent was to be used in a lithotripsy and stone extraction for renal calculi procedure.During unpacking, it was found that the front end of the product was adhered and the middle part of the stent was fractured.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block e1: initial reporter facility name (b)(6).Block h6: device code a0401 captures the reportable event of stent shaft break.Block h11: investigation analysis the device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device, however response was not received.A review of the device history record (dhr) was performed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of stent shaft break and stent kinked was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.Block b5 has been updated based on the additional information received on (b)(6) 2026.

• Brand Name: CONTOUR
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24960862
• Report Number: 2124215-2026-21973
• Device Sequence Number: 16066324
• Product Code: FAD
• UDI-Device Identifier: 08714729058502
• UDI-Public: (01)08714729058502(17)280619(10)36802164
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061802220
• Device Catalogue Number: 180-222
• Device Lot Number: 0036802164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 05/08/2026; 06/05/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 06/04/2026; 07/01/2026
• Date Device Manufactured: 06/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female